The RMM Blog

Updated routinely by Dr. Michael J. Miller, our RMM blog will keep you informed of new and noteworthy technologies, reviews of recent publications and presentations, upcoming conferences and training events, and what's changing in the RMM world. You can also follow our blog on Twitter, Facebook, LinkedIn and RSS.

Tuesday, December 2, 2014

Marking a critical turning point in the fight against Ebola, a new Rapid Ebola Pre-Symptom Screening Test from IES Diagnostics, Inc. can accurately identify if someone is infected with the Ebola virus as early as 24 hours after they contract the virus. This is days to weeks before they are symptomatic and contagious. No other method can test for Ebola infection this early after the virus enters the body.

At this time, the Rapid Ebola Pre-Symptom Screening Test can detect the effects of virus infection within one day of exposure. Researchers anticipate that upcoming validation tests will show this test can detect Ebola effects even earlier--within a few hours of infection, or in less time than a transcontinental airplane trip.

Using a drop of blood, the Rapid Ebola Pre-Symptom Screening Test is designed to detect the unique combination of interferons (called a signature) produced immediately after cells are infected with the Ebola virus. Interferons are the body’s “first responder” proteins, produced only when cells are infected. The Rapid Ebola Pre-Symptom Screening Test can find the body’s interferon signature to Ebola even before the virus itself can be detected.

All other Ebola tests currently used or in development can only diagnose infection when the virus has replicated to levels high enough to be directly detected--typically 8-21 days after infection. At that stage, a person may already be contagious.

Delaying an early, accurate diagnosis can lead to lengthy--and often unnecessary—quarantine periods. Conversely, it can prevent quarantines where needed. For example, the limited sensitivity of current Ebola tests may provide “false negative” results. That may lead an infected person to forego quarantine. This action may unintentionally spread this deadly disease as well as delay an infected individual’s early treatment – significantly decreasing their overall chance of survival. The Rapid Ebola Pre-Symptom Screening Test is a vital tool for detecting Ebola infection earlier, limiting the spread of infection while allowing those infected to be treated earlier.

Once validation tests are completed, the Rapid Ebola Pre-Symptom Screening Test can be readily implemented in the field using existing methods. IES Diagnostics’ test uses PCR (polymerase chain reaction), the same test approach currently used to detect Ebola virus RNA. Also, clinical samples are collected, stored and transported the same way those from antibody Ebola tests are.

This pivotal interferon signature screening tool is the only test in the world that can diagnose a person’s response to Ebola infection several days before viral RNA is measurably detected.

Tests identifying Ebola antibodies through protein detection are less sensitive than IES Diagnostics’ interferon signature testing. Antibody detection tests also are limited in that they must be used when antibody levels are robust enough for detection—days to weeks following exposure. Additionally, antibody tests are surrogate markers of exposure, and do not necessarily indicate active infection.

“Interferon response is the ideal rapid diagnostic tool since it appears immediately after cells are infected with a virus,” explains Ronald Jubin, PhD, molecular biologist and Founder/President of IES Diagnostics, Inc. “Because each response is virus-specific, we can tell if someone has Ebola based on the interferon signature that appears.”

“Being able to test people long before they are contagious is a critical turning point in the fight against Ebola,” Jubin says. “Our ultimate target is to develop a handheld device capable of producing a result within minutes of infection.”

IES Diagnostics’ interferon signature-based technology was developed collaboratively with the US Food and Drug Administration (FDA) and licensed exclusively to IES Diagnostics, Inc. by the US National Institutes of Health (NIH).

IES Diagnostics, Inc. is a molecular diagnostics company in the United States working at the forefront of companion diagnostics and personalized medicine. Its proprietary, patented assay is the first and only test capable of detecting and quantifying all of the unique interferon signatures for any disease or virus with an interferon reaction. Interferon-associated diseases include viral infections, auto-immune diseases (such as lupus, rheumatoid arthritis and multiple sclerosis, among many others) and cancers. With IES Diagnostics’ interferon signature assay, science and medicine have a sensitive, accurate tool to detect and diagnose disease and infection earlier. These signatures also provide disease-specific knowledge that can lead to targeted, effective treatment options with fewer side effects.